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临床试验/NCT07526259
NCT07526259招募中不适用

Comparative Evaluation of Novel 3D Tunneling Technique Versus Modified Coronally Advanced Tunnel (MCAT) With Connective Tissue Graft in the Management of Multiple RT2 Gingival Recession: A Randomized Controlled Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年5月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
36
试验地点
1
主要终点
Gingival recession depth

研究概览

简要总结

Defects associated with severe interdental hard and soft tissue loss are challenging to the periodontist, mainly due to the increased avascular surface and the reduced interproximal periosteal bed. Reports on the surgical techniques used to address recession type 2 or 3 defects mostly showed statistics on the mid-facial root coverage that yielded outcomes that do not encompass coverage of the interdental exposed root surface which highlights areas of controversy in their use for papilla reconstruction. Several case reports and clinical studies have shown encouraging results, but the long-term data are not available in the literature yet. The novel 3D tunneling (3DT) method achieved significant clinical improvement with long term stability in a recent case series. However, additional research is needed to validate 3DT for its routine clinical use. Moreover, the 3DT method achieved a decrease in the lingual recession depth which should be pointed out that the technique also addresses lingual recession.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Buccal and lingual multiple adjacent recession defects classified as Cairo et al RT
  • Age ≥18 years
  • Full mouth plaque index score less than 20% O'Leary et al. 1972
  • Patients with healthy systemic condition
  • Clinical indication and/or patient request for root coverage

排除标准

  • Patients with systemically compromised health
  • Periodontal surgical treatment during the previous 24 months in the involved site
  • Pregnant or lactating mothers
  • Non-compliant patients
  • Restored teeth
  • Non-carious cervical lesion

研究组 & 干预措施

Modified coronally advanced tunnel (MCAT)

Active Comparator

干预措施: Root coverage (Procedure)

novel 3D tunneling (3DT)

Experimental

干预措施: Root coverage (Procedure)

结局指标

主要结局

Gingival recession depth

时间窗: From enrollment to the end of treatment at 1 year

次要结局

  • Periodontal probing depth (PPD) buccal and lingual(From enrollment to the end of treatment at 1 year)
  • Width of keratinized tissue (KTW)(From enrollment to the end of treatment at 1 year)
  • Papilla tip to contact point distance(From enrollment to the end of treatment at 1 year)
  • Gingival recession depth lingual(From enrollment to the end of treatment at 1 year)
  • Clinical attachment level (CAL) buccal and lingual(From enrollment to the end of treatment at 1 year)
  • Mean root coverage(From enrollment to the end of treatment at 1 year)
  • Root coverage esthetic score (RES)(From enrollment to the end of treatment at 1 year)
  • Post operative pain using Visual analogue scale (VAS)(From enrollment to the end of treatment at 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lobna Magdy Mohamed Saber Moawad

Resident

Cairo University

研究点 (1)

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